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FDA 510(k)

AMECATH DUAL LUMEN HEMODIALYSIS CATHETER

K-Number: K123943 · 2013-04-02

ApplicantAmeco Medical Industries
Decision Date2013-04-02
Product CodeMSD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AMECATH DUAL LUMEN HEMODIALYSIS CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Ameco Medical Industries. It received FDA 510(k) clearance on 2013-04-02 under 510(k) number K123943. The device is classified under product code MSD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMECATH DUAL LUMEN HEMODIALYSIS CATHETER?

AMECATH DUAL LUMEN HEMODIALYSIS CATHETER is a medical device that received FDA 510(k) clearance on 2013-04-02. The listed applicant is Ameco Medical Industries. The 510(k) number is K123943.

When did AMECATH DUAL LUMEN HEMODIALYSIS CATHETER receive FDA 510(k) clearance?

AMECATH DUAL LUMEN HEMODIALYSIS CATHETER received FDA 510(k) clearance on 2013-04-02, under 510(k) number K123943.

Who is the listed applicant for AMECATH DUAL LUMEN HEMODIALYSIS CATHETER?

The FDA 510(k) record lists Ameco Medical Industries as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMECATH DUAL LUMEN HEMODIALYSIS CATHETER?

The FDA product code for AMECATH DUAL LUMEN HEMODIALYSIS CATHETER is MSD.

Related Clinical Trials

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Other records listing Ameco Medical Industries as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K152819Amecath Peripheral inserted Central Venous Catheter SetsK131144AMECO SHEATH INTRODUCERK131814AMECATH DUAL LUMEN IMPLANTED HEMODIALYSIS CATHETERK110794AMECATH CVC AND AMECATH PRESSURE CVC SHORT TERM SINGLE AND MULTI-LUMEN CATHERIZATION KITSK110793AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS

Related Devices (Code: MSD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241581Hemodialysis CatheterHaolang Medical USA CorporationK210461End CapMedical Components Inc (Medcomp)K203575GlidePath Retro Long-Term Hemodialysis CatheterC.R. Bard, Inc.K211410GlidePath 13F Long-Term Hemodialysis CatheterBard Peripheral Vascular, Inc.K203767Pristine Long-Term Hemodialysis CatheterC B Bard, Inc.K202150GlidePath 7.5F Long-Term Dialysis CatheterC.R. Bard, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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